(112 days)
Urine Chemistry Analyzer UR-50 is for use with the IND Urinalysis Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity in urine. It can be used for testing in the clinical laboratory setting. For professional use only. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
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The provided text is a 510(k) clearance letter from the FDA for the Urine Chemistry Analyzer UR-50. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the device to legally marketed predicate devices.
- Regulatory classifications and requirements.
- Contact information for further inquiries.
- The intended use of the device, as described in the "Indications for Use" section.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
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This information would typically be found in a separate submission document, such as the 510(k) summary or a detailed clinical study report, which is not part of the provided text.
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.